CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Botox +1 moredrug
Likely dose
Botox 300 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00660192
NCT00660192Phase 3Completed
CompareCT.gov

Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

Yale University·interventional·Posted Apr 17, 2008·Updated Mar 14, 2016

In Brief

A Phase 3 clinical trial evaluating Botox and Placebo for Refractory Migraine. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Migraine
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2012
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.2 years ago

Interventions

Botoxdrug

subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size.

Placeboother

subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.